Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 1999 by NIH AIDS Clinical Trials Information Service.
Recruitment status was Active, not recruiting
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1999
The purpose of this study is to see if it is safe and effective to give adefovir (a new anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other anti-HIV medications.
Drug: Nelfinavir mesylate
Drug: Adefovir dipivoxil
||Endpoint Classification: Safety Study
Primary Purpose: Treatment
||A Phase I/II, Open-Label, Multi-Center Study of the Pharmacokinetics, Safety, Tolerance and Activity of Two Dose Levels of Adefovir Dipivoxil (ADF) and Nelfinavir When Added to Antiretroviral Therapy for the Treatment of HIV-Infected Pediatric Patients
During the first phase of the study (Days 1-6), the safety and tolerability of multiple doses of ADF is assessed when administered simultaneously with the patient's reverse transcriptase inhibitor (RTI) regimen. The second phase begins on Day 7 when nelfinavir is added to the therapy regimen for an additional 15 weeks. ADF pharmacokinetics are measured on Days 1, 2, and 7 (on a subset of 18 patients); peak and trough samples are collected on Day 28.
|Ages Eligible for Study:
||3 Months to 16 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Your child may be eligible for this study if he/she:
- Is 3 months to 16 years old.
- Is HIV-positive.
- Has never taken protease inhibitors or has previously taken ritonavir (RTV), saquinavir (SQV), or indinavir (IDV) and is willing to stop the medication at study entry.
- Is taking an anti-HIV drug combination that will not change during at least the 2 weeks prior to study entry.
- Agrees to use effective barrier methods of birth control, such as condoms, during the study.
- Has consent of parent or guardian.
Your child will not be eligible for this study if he/she:
- Has ever taken NFV.
- Has a history of opportunistic (AIDS-related) infection.
- Has any disease or illness that would prevent him/her from completing the study, including cancer.
- Has taken certain medications, including protease inhibitors at study entry.
- Is receiving an HIV vaccine at study entry.
- Is pregnant.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002219
|All Children's Hosp
|St. Petersburg, Florida, United States, 33731 |
|Tulane Univ Med Ctr / Dept of Pediatrics
|New Orleans, Louisiana, United States, 70112 |
|Bronx Lebanon Hosp Ctr / Dept of Pediatrics
|Bronx, New York, United States, 10457 |
|North Shore Univ Hosp / Division of Immunology
|Great Neck, New York, United States, 11021 |
|St Lukes Roosevelt Hosp Ctr
|New York, New York, United States, 10025 |
|Duke Univ Med Ctr / Duke South Hosp
|Durham, North Carolina, United States, 27710 |
|Med Univ of South Carolina
|Charleston, South Carolina, United States, 29425 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Dose-Response Relationship, Drug
HIV Protease Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Vitamin B Complex
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action